Cosmolock 11-K11-0014

GUDID B07311K1100140

Implant Tray, Cosmolock, Arcamed

Kalitec Direct LLC

Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable
Primary Device IDB07311K1100140
NIH Device Record Keyd2521f0a-c59e-41ab-8aa3-693a589a97a7
Commercial Distribution StatusIn Commercial Distribution
Brand NameCosmolock
Version Model Number11-K11-0014
Catalog Number11-K11-0014
Company DUNS041956211
Company NameKalitec Direct LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB07311K1100140 [Primary]

FDA Product Code

LRPTray, Surgical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B07311K1100140]

Moist Heat or Steam Sterilization


[B07311K1100140]

Moist Heat or Steam Sterilization


[B07311K1100140]

Moist Heat or Steam Sterilization


[B07311K1100140]

Moist Heat or Steam Sterilization


[B07311K1100140]

Moist Heat or Steam Sterilization


[B07311K1100140]

Moist Heat or Steam Sterilization


[B07311K1100140]

Moist Heat or Steam Sterilization


[B07311K1100140]

Moist Heat or Steam Sterilization


[B07311K1100140]

Moist Heat or Steam Sterilization


[B07311K1100140]

Moist Heat or Steam Sterilization


[B07311K1100140]

Moist Heat or Steam Sterilization


[B07311K1100140]

Moist Heat or Steam Sterilization


[B07311K1100140]

Moist Heat or Steam Sterilization


[B07311K1100140]

Moist Heat or Steam Sterilization


[B07311K1100140]

Moist Heat or Steam Sterilization


[B07311K1100140]

Moist Heat or Steam Sterilization


[B07311K1100140]

Moist Heat or Steam Sterilization


[B07311K1100140]

Moist Heat or Steam Sterilization


[B07311K1100140]

Moist Heat or Steam Sterilization


[B07311K1100140]

Moist Heat or Steam Sterilization


[B07311K1100140]

Moist Heat or Steam Sterilization


[B07311K1100140]

Moist Heat or Steam Sterilization


[B07311K1100140]

Moist Heat or Steam Sterilization


[B07311K1100140]

Moist Heat or Steam Sterilization


[B07311K1100140]

Moist Heat or Steam Sterilization


[B07311K1100140]

Moist Heat or Steam Sterilization


[B07311K1100140]

Moist Heat or Steam Sterilization


[B07311K1100140]

Moist Heat or Steam Sterilization


[B07311K1100140]

Moist Heat or Steam Sterilization


[B07311K1100140]

Moist Heat or Steam Sterilization


[B07311K1100140]

Moist Heat or Steam Sterilization


[B07311K1100140]

Moist Heat or Steam Sterilization


[B07311K1100140]

Moist Heat or Steam Sterilization


[B07311K1100140]

Moist Heat or Steam Sterilization


[B07311K1100140]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-01-09
Device Publish Date2019-12-20

On-Brand Devices [Cosmolock]

B07311K0361090Distractor, Fixed Tip
B07311K0361080Compressor, Fixed Tip
B07310K0197010Assembly, Compressor - Distractor Lever, Full MIS
B07310K0123000Recovery Tube, MIS
B07311K1100140Implant Tray, Cosmolock, Arcamed
B07311K1100110Tray Insert 4, Cosmolock, Arcamed
B07311K1100100Tray Insert 3, Cosmolock, Arcamed
B07311K1100090Tray Insert 2, Cosmolock, Arcamed
B07311K1100080Tray Insert 1, Cosmolock, Arcamed
B07311K0600130Tray Insert 3, Cosmolock Deformity
B07311K0600120Tray Insert 5, Cosmolock Deformity
B07310K0690140Tray Insert, MIS Lumbar Instrument 3
B0731010K0690150Tray Insert, MIS Lumbar Instrument 4
B07311K0170200Handheld Fascia Dilator
B07311K0140120Guide, Anti-Splay
B07311K0130120Segmental Rod Reducer Driver
B07311K0130110Segmental Rod Reducer, Slim, Assembly
B07311K0130100Segmental Rod Reducer Assembly
B07311K0100210Caddie Lid, Rods, 5.5mm
B07311K0100200Caddie, Rods, 5.5mm Assembly
B07311K0100060Tray Insert, Lumbar Screws, 10 x 10 Assembly
B07311K1430210Rod Template, 500mm
B07311K1430200Rod Template, 250mm
B07311K0316920Probe, 1.75" Egg, Steffee, Long, Straight, Impact
B07311K0150050Sizer, Fixed Crosslink Assembly
B07311K0120220Assembly, Screwdriver, Extended Tab
B07311K0120210Assembly, Screwdriver, Extended Tab, Cannulated, Lockable
B07311K0120150Assembly, Screwdriver, Polyaxial, Lockable
B073DRK0100280Tab Breaker, Single Sided, Cosmolock MIS
B07310K1190140Tray Insert 6, Cosmo MIS,Arcamed
B07310K1190130Tray Insert 5, Cosmo MIS,Arcamed
B07310K1190120Tray Insert 4, Cosmo MIS, Arcamed
B07310K1190100Tray Insert 3, Cosmo MIS, Arcamed
B07310K1190090Tray Insert 2, Cosmo MIS, Arcamed
B07310K1190080Tray Insert 1, Cosmo MIS, Arcamed
B07310K0690130Tray Insert, MIS Lumbar Instruments 2
B07310K0690120Tray Insert, MIS Lumbar Instruments 1
B07310K0690100Tray Insert, MIS Lumbar Implants 3
B07310K0690090Tray Insert, MIS Lumbar Implants 2
B07310K0690080Tray Insert, MIS Lumbar Implants
B073DRK0100300Sagittal Bender, Straight
B07311RRC02000Rod, Curved, 5.50 x 200mm
B07311RRC01900Rod, Curved, 5.50 x 190mm
B07311RRC01800Rod, Curved, 5.50 x 180mm
B07311RRC01700Rod, Curved, 5.50 x 170mm
B07311RRC01600Rod, Curved, 5.50 x 160mm
B07311RRC01500Rod, Curved, 5.50 x 150mm
B07311RRC01400Rod, Curved, 5.50 x 140mm
B07311RRC01300Rod, Curved, 5.50 x 130mm
B07310NTN06100Guidewire, NiTi Trocar, Non-Threaded 610mm

Trademark Results [Cosmolock]

Mark Image

Registration | Serial
Company
Trademark
Application Date
COSMOLOCK
COSMOLOCK
85810036 4602203 Live/Registered
Kalitec Direct, LLC
2012-12-24

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